A Phase I/II Dose Escalation Study to Assess the Safety, Tolerability and Efficacy of AmphinexTM-induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy in Patients with Advanced Inoperable Cholangiocarcinomas

PCI Biotech AS0 sites61 target enrollmentFebruary 28, 2014

Overview

No summary available.

Registry

who.int

Start Date

February 28, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\. Histopathologically/cytologically (C5\) verified adenocarcinoma consistent with cholangiocarcinoma.
•2\. Cholangiocarcinoma that:
•\- Is considered to be inoperable
•\- Is a primary lesion in the perihilar biliary duct region that requires stent placement
•\- Has nodal enlargement \= to N1 as per CT/MRI assessment
•\- If has metastatic disease; this should be confined to the liver parenchyma only
•3\. Adequate biliary drainage (either at least 50% of the liver volume, or at least two sectors), with no evidence of active uncontrolled infection (patients on antibiotics are eligible).
•4\. Age \= 18 years.
•5\. Performance status ECOG \= 1
•6\. Estimated life expectancy of at least 12 weeks.

•1\. Any prior anti\-cancer (either local or systemic) treatment for cholangiocarcinoma.
•2\. Patients with extra\-hepatic metastatic cholangiocarcinoma.
•3\. Patients with a severe visceral disease other than cholangiocarcinoma.
•4\. Patients with primary sclerosing cholangitis.
•5\. Patients with porphyria or hypersensibility to porphyrins.
•6\. Patients with an active second primary cancer, with exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non\-melanomatous skin cancer, or in\-situ carcinoma of the uterine cervix. An active second primary cancer is defined as one with a disease\-free interval of \< 5 years before registration/randomization.
•7\. Inability to undergo CT or MRI.
•8\. Current participation in any other interventional clinical trial.
•9\. Male patients not willing to use adequate contraception or female patients of childbearing potential not willing to use an effective form of contraception such as hormonal birth control, intrauterine device or double barrier method during PCI treatment and subsequent chemotherapy and for at least 6 months thereafter.
•10\. Breast feeding women or women with a positive pregnancy test at baseline.